510(k) K211949
- Device
- AirStrip ONE Web Client With Alarm Communication Management (ACM)
- Applicant
- AirStrip Technologies, Inc.
- 510(k) number
- K211949
- Product code
- MSX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-12-09
- Date received
- 2021-06-23
- Regulation
- 870.2300
- Classification name
- System, Network And Communication, Physiological Monitors
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Clearance type
- Special
- Third party reviewed
- No
Other 510(k) Records For Product Code MSX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253654 | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH | 2026-03-30 |
| K243270 | TigerConnect Alarm Management | Tigerconnect | 2025-09-30 |
| K242728 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-07-31 |
| K242750 | Central Station | Nihon Kohden Digital Health Solutions, LLC | 2025-06-05 |
| K242842 | ANNE View, Central Hub | Sibel Health, Inc. | 2025-01-08 |
| K241397 | Hinscope | Hinlab Sas | 2024-11-14 |
| K233834 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2024-07-12 |
| K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 2024-05-09 |
| K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2024-03-22 |
| K231506 | Current Health System | Current Health , Ltd. | 2023-08-24 |
| K223567 | CNS-2101 Central Monitor | Nihon Kohden Corporation | 2023-07-31 |
| K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | 2023-02-23 |
| K222550 | Current Health System | Current Health , Ltd. | 2022-11-01 |
| K203579 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2022-06-07 |
| K211046 | eCareManager 4.5 | Visicu, Inc. | 2022-06-03 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases